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NCT Number: NCT01310985

A Trial of Pre-Operative Chemoradiotherapy Using Capecitabine, Radiation & Cetuximab, in Rectal Cancer

A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer

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Key information

Conditions

Colon Rectal Cancer Duke Stage Stageval Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

14 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kfsh & Rc

Riyadh, Saudi Arabia

About this study

Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Localized Non-Metastatic Rectal Cancer

Exclusion criteria

  • Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer

Treatment and study plan

Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)

Drug

Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)

Other names: Capecitabine (Xelodaâ), XRT& Cetuximab (Erbitux®)

Primary outcomes

  1. Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation.

    Time frame: For the duration of the experiment

Secondary outcomes

  1. Evaluate efficacy of sphincter preserving surgery rate, local recurrence rate and the disease free and overall survival in patients.

    Time frame: For the duration of the experiment

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 9, 2011
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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